ACICLOVIR Aciclovirum

C8H11N5O3

P.t.l: 225,2

Aciclovir l 2-amino-9-[(2-hydroxyethoxy)methyl]-1,9-dihydro-6H-purin-6-on, phi cha t 98,5 n 101,0% C8H11N5O3, tnh theo ch phm khan. Tnh cht Bt kt tinh mu trng hoc gn nh trng. Kh tan trong nc, d tan trong dimethyl sulfoxyd, rt kh tan trong ethanol 96%. Tan trong cc dung dch acid v c v hydroxyd kim long. nh tnh Ph hng ngoi (Ph lc 4.2) ca ch phm phi ph hp vi ph hng ngoi ca aciclovir chun (C). trong v mu sc ca dung dch Ho tan 0,25 g ch phm trong dung dch natri hydroxyd 0,1 M (TT) v pha long thnh 25 ml vi cng dung mi. Dung dch phi trong (Ph lc 9.2) v khng c c mu m hn mu mu V 7 (Ph lc 9.3, phng php 2). Tp cht lin quan Khng c qu 1%. Xc nh bng phng php sc k lp mng (Ph lc 5.4). Bn mng: Silica gel GF254 (TT). Dung mi khai trin: Cloroform - methanol - amoniac m c (80 : 20 : 2). Dung dch th: Ha tan 0,1 g ch phm trong dimethyl sulfoxyd (TT) v pha long thnh 10 ml vi cng dung mi. Dung dch i chiu: Pha long 1,0 ml dung dch th thnh 100 ml bng dimethyl sulfoxyd (TT). Cch tin hnh: Chm ring bit ln bn mng 5 l mi dung dch trn. Trin khai sc k ti khi dung mi i c khong 15 cm, ly bn mng ra, kh trong khng kh v quan st di nh sng t ngoi bc sng 254 nm v 366 nm. Bt k vt ph no trn sc k ca dung dch th cng khng c m mu hn vt chnh trn sc k ca dung dch i chiu. Guanin Khng c qu 0,7 %. Xc nh bng phng php sc k lng (Ph lc 5.3). Pha ng: Acid acetic bng - nc (1 : 999). Dung dch 1: Ho tan mt lng cn chnh xc aciclovir chun (C) v guanin chun (C) trong dung dch natri hydroxyd 0,1 N (TT) v pha long vi nc thu c dung dch c nng chnh xc ca mi cht khong 0,1 mg/ml. 1

Dung dch 2: Ho tan mt lng cn chnh xc guanin chun (C) trong dung dch natri hydroxyd 0,1 N (TT) v pha long vi nc thu c dung dch c nng chnh xc khong 0,7 g/ml. Dung dch chun guanin: Cn chnh xc khong 8,75 mg guanin chun (C) vo bnh nh mc 500 ml. Ho tan trong 50 ml dung dch natri hydroxyd 0,1 N (TT), pha long vi nc n vch v lc u. Ly 2,0 ml dung dch ny vo bnh nh mc 50 ml, pha long vi dung dch natri hydroxyd 0,01 N (TT) n vch v lc u thu c dung dch c nng chnh xc khong 0,7 g/ml. Dung dch th: Ha mt lng cn chnh xc khong 100 mg ch phm trong 20 ml dung dch natri hydroxyd 0,1 N (TT) trong bnh nh mc 200 ml, pha long vi nc n vch v lc u. Ly 10,0 ml dung dch ny vo bnh nh mc 50 ml v pha long vi dung dch natri hydroxyd 0,01 N (TT) n vch v lc u. iu kin sc k: Ct thp khng g (30 cm 4,2 mm) c nhi pha tnh C (3 - 10 m). Detector quang ph hp th t ngoi bc sng 254 nm. Tc dng: 3 ml/ pht. Th tch tim: 20 l. Cch tin hnh: Tim dung dch 1: phn gii gia pic ca aciclovir v guanin khng c nh hn 2,0. H s i xng ca pic guanin khng c ln hn 2. Tim dung dch 2: lch chun tng i gia cc ln tim ca chiu cao hoc din tch pic guanin khng c ln hn 2,0%. Tim ln lt dung dch chun guanin v dung dch th. Tnh hm lng % ca guanin trong ch phm theo chiu cao hoc din tch pic ca guanin trong dung dch chun guanin v dung dch th. Nc Khng c qu 6,0% (Ph lc 10.3). Dng 0,500 g ch phm. Tro sulfat Khng c qu 0,1%. (Ph lc 9.9, phng php 2). Dng 1,0 g ch phm. nh lng Ha tan 0,150 g ch phm trong 60 ml acid acetic khan (TT). Chun bng dung dch acid percloric 0,1 N (C). Xc nh im kt thc bng phng php chun o in th (Ph lc 10.2). Song song lm mu trng trong cng iu kin. 1 ml dung dch acid percloric 0,1 N (C) tng ng vi 22,52 mg C8H11N5O3. Bo qun Trong ng kn. Loi thuc Thuc khng virus. Ch phm Kem, thuc m tra mt, dung dch tim truyn, hn dch ung, vin nn.